RT II Gingival RecessionNCT07771244
Hyaluronic Acid and Polynucleotides With Connective Tissue Graft and Coronally Advanced Flap for RT II Gingival Recession
A study testing Coronally Advanced Flap with Connective Tissue Graft and Hyaluronic Acid/Polynucleotides in people with RT II Gingival Recession, run by Cairo University at 1 site in Egypt.
Trial summary
This case series will evaluate the effectiveness of injectable hyaluronic acid combined with polynucleotides as an adjunct to coronally advanced flap and connective tissue graft in patients with RT II gingival recession. Twelve patients will be included and followed for 6 months. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- RT II Gingival Recession
- What is being tested?
- Coronally Advanced Flap with Connective Tissue Graft and Hyaluronic Acid/Polynucleotides
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with RT II gingival recession.
- Age range: 15-60 years.
- Systemically healthy patients with no contraindications to surgery.
- Patients who have not had previous periodontal surgery in the area of treatment.
Who cannot join
- Periodontitis.
- Active systemic disease affecting wound healing.
- Pregnancy or breastfeeding.
- Improperly aligned teeth or teeth with cervical restorations or crowns.
- Non-carious cervical lesions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo
HASSAN NIDAL FANDI, BDS, +201011066726, hassan.fandi@dentistry.cu.edu.eg
About this study
Official title: Assessment of Injectable Hyaluronic Acid Combined With Polynucleotides With Coronally Advanced Flap and Connective Tissue Graft in Treatment of RT II Gingival Recession Defects for Covering Gingival Recession
This case series will evaluate the effectiveness of injectable hyaluronic acid combined with polynucleotides as an adjunct to coronally advanced flap and connective tissue graft in patients with RT II gingival recession. Twelve patients will be included and followed for 6 months. Clinical outcomes will include percentage of root coverage, clinical attachment level gain, gingival thickness, probing depth, width of keratinized tissue, post-operative pain, and patient aesthetic satisfaction.
Read the detailed description
Patients with RT II gingival recession will be treated using a coronally advanced flap combined with a de-epithelialized connective tissue graft. Approximately 1-2 mL of a hyaluronic acid and polynucleotide mixture will be applied to the graft before suturing. Patients will be followed for 6 months. Clinical measurements will include recession depth and width, percentage of root coverage, clinical attachment level, gingival thickness, probing depth, keratinized tissue width, post-operative pain, and patient esthetic satisfaction.
- Conditions
- RT II Gingival Recession
- Being tested
- Coronally Advanced Flap with Connective Tissue Graft and Hyaluronic Acid/Polynucleotides
- Keywords
- Gingival Recession, RT II Gingival Recession, Hyaluronic Acid, Polynucleotides, Coronally Advanced Flap, Connective Tissue Graft
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronally Advanced Flap with Connective Tissue Graft and Hyaluronic Acid/PolynucleotidesProcedure or surgery
A coronally advanced flap will be performed with a de-epithelialized connective tissue graft. Approximately 1-2 mL of a hyaluronic acid and polynucleotide mixture will be applied to the graft before suturing
| Study group | Role | What they receive |
|---|---|---|
| CAF + CTG + Hyaluronic Acid and Polynucleotides | Experimental | Participants with RT II gingival recession will receive coronally advanced flap surgery with a de-epithelialized connective tissue graft combined with hyaluronic acid and polynucleotides. Receives: Procedure: Coronally Advanced Flap with Connective Tissue Graft and Hyaluronic Acid/Polynucleotides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Root Coverage
Percentage of root coverage will be calculated using the following formula: (Initial Recession Depth - Post-Treatment Recession Depth) / Initial Recession Depth × 100.
Measured: Baseline, 1 month, 3 months, and 6 months
Clinical Attachment Level (CAL) Gain
Clinical attachment level will be measured in millimetres using a UNC-15 periodontal probe
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (7)
Recession Depth
Gingival recession depth will be measured in millimeters using a UNC-15 periodontal probe
Measured: Baseline, 3 months, and 6 months
Recession Width
Gingival recession width will be measured in millimeters using a UNC-15 periodontal probe.
Measured: Baseline, 3 months, and 6 months
Gingival Thickness
Gingival thickness will be measured in millimeters using an endodontic file
Measured: Baseline, 3 months, and 6 months
Probing Depth
Probing depth will be measured in millimeters using a UNC-15 periodontal probe.
Measured: Baseline, 3 months, and 6 months
Width of Keratinized Tissue
Keratinized tissue width will be measured in millimeters using a UNC-15 periodontal probe
Measured: Baseline, 3 months, and 6 months
Post-Operative Pain
Post-operative pain will be assessed using a Visual Analogue Scale (VAS) questionnaire, with scores ranging from 1 to 10
Measured: 1 week post-surgery
Patient Esthetic Satisfaction
Patient esthetic satisfaction will be assessed using a Visual Analogue Scale (VAS) questionnaire, with scores ranging from 1 to 10
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RT II Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the same intervention consisting of coronally advanced flap and connective tissue graft combined with hyaluronic acid and polynucleotides.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hassan nidal fandi, Cairo University
- Investigators
- HASSAN NIDAL FANDI, BDS, Principal investigator, Cairo UniversityDr.Manal Hosny, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771244
- Sponsor's protocol ID
- PER 3__3__1
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers in order to maintain participant confidentiality and data privacy. Access to the study data will be limited to the principal investigator and supervisors.
Publications
Zucchelli G, Amore C, Sforza NM, Montebugnoli L, De Sanctis M. Bilaminar techniques for the treatment of recession-type defects. A comparative clinical study. J Clin Periodontol. 2003 Oct;30(10):862-70. doi: 10.1034/j.1600-051x.2003.00397.x.
PubMed 14710766Han HS, Shin HR, Kim S, Cho YD. Polynucleotide with cross-linked hyaluronic acid reduces inflammation and increases collagen synthesis. J Periodontal Implant Sci. 2025 Jun;55(3):206-216. doi: 10.5051/jpis.2402520126. Epub 2025 Jan 30.
PubMed 40047180Pilloni A, Schmidlin PR, Sahrmann P, Sculean A, Rojas MA. Effectiveness of adjunctive hyaluronic acid application in coronally advanced flap in Miller class I single gingival recession sites: a randomized controlled clinical trial. Clin Oral Investig. 2019 Mar;23(3):1133-1141. doi: 10.1007/s00784-018-2537-4. Epub 2018 Jun 30.
PubMed 29961138
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Injectable Hyaluronic Acid Combined With Polynucleotides With Coronally Advanced Flap and Connective Tissue Graft in Treatment of RT II Gingival Recession Defects for Covering Gingival Recession
- ClinicalTrials.gov ID
- NCT07771244
- Acronym / sponsor ID
- PER 3__3__1
- Conditions
- RT II Gingival Recession
- Keywords
- Gingival Recession, RT II Gingival Recession, Hyaluronic Acid, Polynucleotides, Coronally Advanced Flap, Connective Tissue Graft
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This case series will evaluate the effectiveness of injectable hyaluronic acid combined with polynucleotides as an adjunct to coronally advanced flap and connective tissue graft in patients with RT II gingival recession. Twelve patients will be included and followed for 6 months. Clinical outcomes will include percentage of root coverage, clinical attachment level gain, gingival thickness, probing depth, width of keratinized tissue, post-operative pain, and patient aesthetic satisfaction.
Detailed description
Patients with RT II gingival recession will be treated using a coronally advanced flap combined with a de-epithelialized connective tissue graft. Approximately 1-2 mL of a hyaluronic acid and polynucleotide mixture will be applied to the graft before suturing. Patients will be followed for 6 months. Clinical measurements will include recession depth and width, percentage of root coverage, clinical attachment level, gingival thickness, probing depth, keratinized tissue width, post-operative pain, and patient esthetic satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same intervention consisting of coronally advanced flap and connective tissue graft combined with hyaluronic acid and polynucleotides.
| Arm | Type | Receives |
|---|---|---|
| CAF + CTG + Hyaluronic Acid and Polynucleotides | Experimental | Procedure: Coronally Advanced Flap with Connective Tissue Graft and Hyaluronic Acid/PolynucleotidesParticipants with RT II gingival recession will receive coronally advanced flap surgery with a de-epithelialized connective tissue graft combined with hyaluronic acid and polynucleotides. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with RT II gingival recession.
- Age range: 15-60 years.
- Systemically healthy patients with no contraindications to surgery.
- Patients who have not had previous periodontal surgery in the area of treatment.
Key exclusion criteria (5 listed)
- Periodontitis.
- Active systemic disease affecting wound healing.
- Pregnancy or breastfeeding.
- Improperly aligned teeth or teeth with cervical restorations or crowns.
- Non-carious cervical lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronally Advanced Flap with Connective Tissue Graft and Hyaluronic Acid/PolynucleotidesA coronally advanced flap will be performed with a de-epithelialized connective tissue graft. Approximately 1-2 mL of a hyaluronic acid and polynucleotide mixture will be applied to the graft before suturing | Procedure or surgery | CAF + CTG + Hyaluronic Acid and Polynucleotides |
Primary outcome
Percentage of Root Coverage
Time frame: Baseline, 1 month, 3 months, and 6 months
Percentage of root coverage will be calculated using the following formula: (Initial Recession Depth - Post-Treatment Recession Depth) / Initial Recession Depth × 100.
Clinical Attachment Level (CAL) Gain
Time frame: Baseline, 3 months, and 6 months
Clinical attachment level will be measured in millimetres using a UNC-15 periodontal probe
7 secondary outcomes
Recession Depth
Time frame: Baseline, 3 months, and 6 months
Recession Width
Time frame: Baseline, 3 months, and 6 months
Gingival Thickness
Time frame: Baseline, 3 months, and 6 months
Probing Depth
Time frame: Baseline, 3 months, and 6 months
Width of Keratinized Tissue
Time frame: Baseline, 3 months, and 6 months
Post-Operative Pain
Time frame: 1 week post-surgery
Patient Esthetic Satisfaction
Time frame: 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 14710766Zucchelli G, Amore C, Sforza NM, Montebugnoli L, De Sanctis M. Bilaminar techniques for the treatment of recession-type defects. A comparative clinical study. J Clin Periodontol. 2003 Oct;30(10):862-70. doi: 10.1034/j.1600-051x.2003.00397.x.
- Background: PubMed 40047180Han HS, Shin HR, Kim S, Cho YD. Polynucleotide with cross-linked hyaluronic acid reduces inflammation and increases collagen synthesis. J Periodontal Implant Sci. 2025 Jun;55(3):206-216. doi: 10.5051/jpis.2402520126. Epub 2025 Jan 30.
- Background: PubMed 29961138Pilloni A, Schmidlin PR, Sahrmann P, Sculean A, Rojas MA. Effectiveness of adjunctive hyaluronic acid application in coronally advanced flap in Miller class I single gingival recession sites: a randomized controlled clinical trial. Clin Oral Investig. 2019 Mar;23(3):1133-1141. doi: 10.1007/s00784-018-2537-4. Epub 2018 Jun 30.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers in order to maintain participant confidentiality and data privacy. Access to the study data will be limited to the principal investigator and supervisors.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
HASSAN NIDAL FANDI, BDS principal investigator
Cairo University
Dr.Manal Hosny study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronally Advanced Flap with Connective Tissue Graft and Hyaluronic Acid/Polynucleotides in people with RT II Gingival Recession, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HASSAN NIDAL FANDI, BDS (+201011066726, hassan.fandi@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Root Coverage (time frame: Baseline, 1 month, 3 months, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07771244, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.